Acromegaly MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Active acromegaly on pegvisomant monotherapy at a stable dose with a normal age-adjusted serum IGF-I for at least 3 months Over 18 years of age Willing to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unwilling or unable to provide informed consent Other conditions known to alter IGF-I levels (severe hepatic disease, severe renal disease, malnutrition, ethanol and drug abuse) Abnormal liver enzymes Pregnancy/lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimum range of serum IGF1 that is to be used as a target for treatment of acromegaly with pegvisomant.;Secondary Objective: ;Primary end point(s): The study will conclude when all patients have completed 12 weeks with a subnormal IGF1 and have repeated all the measurements required. | — |
Countries
United Kingdom